At a glance
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A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
In Brief
A Phase 3 clinical trial evaluating Cisplatin, Oxaliplatin, and 5 other interventions for Esophageal Squamous Cell Carcinoma (ESCC). Completed, enrolled 649 participants across 124 sites in 16 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
Study Details
Timeline
Interventions
Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan.
Oxaliplatin 130 mg/m² administered by intravenous infusion every 3 weeks.
Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle.
Capecitabine 1000 mg/m² administered orally twice daily on Days 1-14 of each treatment cycle
Paclitaxel 175 mg/m² administered by intravenous infusion every 3 weeks.
Tislelizumab 200 mg administered by intravenous infusion every 3 weeks.
Placebo to match tislelizumab administered by intravenous infusion every 3 weeks.